K233321

Substantially Equivalent

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

Applicant: FUJIFILM Healthcare Americas Corporation
Product code: FDA
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-29
Decision date: 2024-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.